Ignite Creation Date:
2025-12-24 @ 6:25 PM
Ignite Modification Date:
2026-02-05 @ 8:47 PM
Study NCT ID:
NCT03644368
Status:
COMPLETED
Last Update Posted:
2019-04-18
First Post:
2018-07-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Children's Deep Neck Infections at the Montpellier Hospital
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 83}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-17', 'studyFirstSubmitDate': '2018-07-02', 'studyFirstSubmitQcDate': '2018-08-21', 'lastUpdatePostDateStruct': {'date': '2019-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'duration of hospitalization', 'timeFrame': '1 day', 'description': 'Compare the duration of hospitalization enter the group treated by alone antibiotic and the group treated by antibiotic and surgical drainage.'}, {'measure': 'duration of the fever', 'timeFrame': '1 day', 'description': 'Compare the duration of the fever enter the group treated by alone antibiotic and the group treated by antibiotic and surgical drainage.'}], 'primaryOutcomes': [{'measure': 'Clinical description of acute peripharyngeal suppuration', 'timeFrame': '1 day', 'description': 'Clinical description of acute peripharyngeal suppuration suppuration'}], 'secondaryOutcomes': [{'measure': 'Description of therapeutic management', 'timeFrame': '1 day', 'description': 'Description of therapeutic management : vaccinations, treatments received before hospitalization, treatments received during hospitalization'}, {'measure': 'Description of bacteria in deep neck infections', 'timeFrame': '1 day', 'description': 'Description of bacteria in deep neck infections'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cervical phlegmon', 'tonsillar abscesses', 'retropharyngeal or parapharyngeal abscesses', 'medical and chirurgical treatment', 'Bacteria in deep neck infections'], 'conditions': ['Deep Neck Infections']}, 'descriptionModule': {'briefSummary': 'To descride the clinical presentation, diagnosis, management and complications of children with a deep neck infection. A retrospective chart review was conducted at the Montpellier hospital in France. All children aged less than 18 years who had been admitted with a diagnosis of cervical phlegmon, tonsillar abscesses, retropharyngeal or parapharyngeal abscesses between January 2015 and December 2017 were included. The investigators collected the demographic, biological, radiological data and treatment received of the patients to the admision. The results of the bacteriological samples were collected. The investigators compared our results to those of the 10-year cohort. The investigators wish to compare the duration of hospitalization and the duration of the fever enter the group treated by alone antibiotic and the group treated by antibiotic and surgical drainage'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '1 Month', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Children hospitalized for acute pharyngeal infection', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* under 18 years old\n* hospitalized for acute pharyngeal infection ( cervical phlegmon, tonsillar abscesses, retropharyngeal or parapharyngeal abscesses)\n\nExclusion criteria:\n\n* neck infection in the context of immune deficiency\n* malignancy or post-traumatic disease\n* others deep neck infections: angina, otitis, sinusitis, ethmoiditis, mastoiditis.'}, 'identificationModule': {'nctId': 'NCT03644368', 'briefTitle': "Children's Deep Neck Infections at the Montpellier Hospital", 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': "Retrospective Evaluation of the Management of Children's Deep Neck Infections at the Montpellier Hospital", 'orgStudyIdInfo': {'id': 'RECHMPL18_0212'}}, 'contactsLocationsModule': {'locations': [{'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'Uhmontpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}], 'overallOfficials': [{'name': 'Eric JEZIORSKI', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Montpellier'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'NC'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}